Biora Therapeutics announced on November 4, 2026, that it has received Human Research Ethics Committee (HREC) approval to proceed with a first-in-human clinical study of its BioJet capsule in Australia.¹ The study is expected to evaluate the safety, tolerability, and pharmacokinetics of adalimumab delivered orally by the ingestible device in healthy volunteers, compared with subcutaneous injection.¹ Biora said it remains on track to begin dosing in December 2026, with data expected in early 2027.¹
Key facts
- Company: Biora Therapeutics (BT Bidco, Inc.; privately held)
- Device: BioJet capsule (ingestible liquid jet delivery device, 00 size)
- Drug studied: adalimumab, oral via BioJet vs subcutaneous injection
- Trial: first-in-human; healthy volunteers; Australia
- Endpoints: safety, tolerability, and pharmacokinetics
- Approval: Human Research Ethics Committee (HREC)
- Timing: dosing planned for December 2026; data expected early 2027
- Preclinical: more than 800 capsules dosed in swine, canines, and nonhuman primates
- Regulatory status: investigational; not approved for commercial use
"Receiving HREC approval keeps us on track with our goal to begin dosing subjects by December," said Adi Mohanty, CEO of Biora Therapeutics. "The BioJet capsule has the potential to reduce the burden that patients face with chronic self-injections."¹
How does the BioJet capsule work?
The BioJet capsule is an ingestible, single-use device the size of a 00 capsule that uses liquid jet technology to deliver drug into the small intestine for systemic uptake.¹ The platform is designed to accommodate existing liquid drug formulations without reformulation. Biora intends it as a needle-free alternative for proteins, antibodies, and other biomolecules.¹ The company said that if successful, the device could help convert injectable therapies into oral dosage forms.¹ The device is investigational and not approved for commercial use. Biora holds more than 20 granted patents covering the platform in the US, Europe, Japan, and China.¹
Why is adalimumab being used in the first human study?
Adalimumab is a widely used biologic currently administered by injection, and Biora said its extensive clinical data provide a well-characterized reference for analyzing the study results.¹ The company is using adalimumab to evaluate whether the device can provide systemic delivery of an existing biologic formulation through an oral, needle-free approach.¹
What preclinical data support the program?
Biora reported that more than 800 BioJet capsules have been dosed across large-animal models, including swine, canines, and nonhuman primates. It said the platform has been evaluated for oral delivery of monoclonal antibodies, peptides, and oligonucleotides.¹
Biora first announced plans for the trial in September 2026. BioPharm International reported at the time that the company expected the first-in-human study to begin by the end of 2026, with data that could support a 2027 regulatory filing for further clinical development.² Earlier, in 2023, Biora reported preclinical results for a previous version of its liquid jet delivery device. In a porcine model of 9 animals, the device achieved an average bioavailability of 51.3% for a 56-mg dose of Biora's adalimumab variant, with variability similar to subcutaneous injection.³
